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    Summary
    EudraCT Number:2021-004795-34
    Sponsor's Protocol Code Number:AT-1501-N205
    National Competent Authority:Poland - Office for Medicinal Products
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2022-09-05
    Trial results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedPoland - Office for Medicinal Products
    A.2EudraCT number2021-004795-34
    A.3Full title of the trial
    A Phase 2a, Multicenter, Open-Label Study to Evaluate the Safety and Efficacy of AT-1501 in Patients with IgA Nephropathy
    Wieloośrodkowe, prowadzone metodą otwartej próby badanie fazy 2a mające na celu ocenę bezpieczeństwa i skuteczności stosowania AT-1501 u pacjentów z nefropatią IgA
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Safety and Efficacy of AT-1501 in Patients with IgAN
    A.3.2Name or abbreviated title of the trial where available
    Safety and Efficacy of AT-1501 in Patients with IgAN
    A.4.1Sponsor's protocol code numberAT-1501-N205
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT05125068
    A.5.3WHO Universal Trial Reference Number (UTRN)U1111-1269-7356
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorEledon Pharmaceuticals, Inc
    B.1.3.4CountryUnited States
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportEledon Pharmaceuticals, Inc
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationGeorge Clinical (UK), Ltd.
    B.5.2Functional name of contact pointChris Christodoulou
    B.5.3 Address:
    B.5.3.1Street AddressCentrum House, 36 Station Road
    B.5.3.2Town/ cityEgham, Surrey
    B.5.3.3Post codeTW20 9LF
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number+447768 415726
    B.5.6E-mailcchristodoulou@georgeclinical.com
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameAT-1501
    D.3.2Product code AT-1501
    D.3.4Pharmaceutical form Lyophilisate for solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNNot yet assigned
    D.3.9.1CAS number 2628092-47-5
    D.3.9.2Current sponsor codeAT-1501
    D.3.9.3Other descriptive nameNot yet assigned
    D.3.9.4EV Substance CodeAS1
    D.3.10 Strength
    D.3.10.1Concentration unit mg/kg milligram(s)/kilogram
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    IgA Nephropathy
    E.1.1.1Medical condition in easily understood language
    Autoimmune kidney disease with gradually increasing proteinuria
    E.1.1.2Therapeutic area Diseases [C] - Immune System Diseases [C20]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.1
    E.1.2Level PT
    E.1.2Classification code 10029151
    E.1.2Term Nephropathy
    E.1.2System Organ Class 10038359 - Renal and urinary disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Objectives:

    • To assess the effect of AT-1501 on reduction of proteinuria in patients with IgAN
    • To assess the safety of AT-1501 in patients with IgAN
    • To assess the effect of AT-1501 on biomarkers associated with IgAN
    • To assess the effect of AT-1501 on estimated glomerular filtration rate (eGFR) in patients with IgAN
    E.2.2Secondary objectives of the trial
    Secondary:
    • The change in eGFR slope from baseline to 96 weeks
    • The change in urine protein excretion over time
    • The percentage of patients who develop anti-drug antibodies (ADAs)

    Exploratory: Change from baseline in serum biomarkers: o Gd-IgA1 o Total IgA
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Inclusion Criteria: Patients are eligible for the study if they meet all of the following criteria at the time of Screening: 1. Able to understand the key components of the study as described in the written ICF, and are willing and able to provide written informed consent; 2. Male or female ≥ 18 years of age; 3. Biopsy proven IgAN (regardless of how long before Screening the biopsy was performed to make the diagnosis); 4. Urine protein ≥ 0.75g/24 hours at Screening despite optimization with ACE inhibitors or angiotensin receptor blockers (ARB); 5. eGFR ≥ 45 mL/min per 1.73 m2 OR eGFR < 45 mL/min per 1.73 m2 and ≥ 30 mL/min per 1.73 m2.with a kidney biopsy within 2 years of Screening showing < 50% tubulointerstitial fibrosis. 6. Willing and able to comply with the study requirements, including prohibited concomitant medication restrictions; 7. Agree not to participate in another interventional study while participating in this study; 8. If female, is surgically sterile or 12 months postmenopausal. Women of childbearing potential may be enrolled if a serum pregnancy test is negative at Screening/Baseline. Women of childbearing potential and men with partners who are of childbearing potential must agree to use highly effective methods of contraception from Screening, through the EoS Visit. Contraception use must continue for 90 days after the last administration of the study drug. Examples of acceptable methods of contraception which must be used together are described in Table 3. 9. If male, agrees to use a medically accepted highly effective method of contraception and agrees to use this method for 90 days after last administration of the study drug; and agrees to not donate sperm for 90 days after last administration of the study drug; 10. If eligible for COVID-19 vaccination in their jurisdiction per local guidelines, have received a complete COVID-19 immunization schedule at least 30 days prior to Screening.
    E.4Principal exclusion criteria
    Exclusion Criteria: Patients are excluded from the study if any of the following criteria apply: 1. Any secondary IgAN as defined by the Investigator; 2. Patients who have undergone a kidney transplant; 3. Current extrarenal involvement (skin, joints, gastrointestinal tract) suggestive of a diagnosis of IgA vasculitis; prior diagnosis of IgA vasculitis is not exclusionary; 4. Any history of kidney disease other than IgAN; 5. Any history of diabetes (Type 1 or Type 2); 6. Seated blood pressure > 140 mmHg (systolic) or > 90 mmHg (diastolic) at the Screening Visit. Patients must be on a stable dose and regimen of an ACE inhibitor or ARB for at least 90 days. If necessary, the medication may be adjusted to control for hypertension and hypotension; 7. Clinically significant abnormal ECG at Screening; 8. Thrombocytopenia (platelets < 75,000 per mm3), leukopenia (WBC < 4,000 per µL) or anemia (hemoglobin < 8 g/dL) at Screening; 9. Significant liver disease, defined as having elevated aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) levels greater than 2 times the upper limit of normal (ULN), per the central laboratory; 10. Pregnancy or breastfeeding; 11. History of a TE event, known hypercoagulable state, or condition requiring long-term anticoagulation; 12. Current malignancy or a history of malignancy (within the past 5 years), except nonmetastatic basal or squamous cell carcinoma of the skin that has been treated successfully; 13. Current or history of active tuberculosis infection except if there is a documented bacille Calmette-Guérin (BCG) vaccination and a negative chest x-ray. Laboratory evidence of infection (positive purified protein derivative or QuantiFERON-TB Gold) in the absence of clinical infection is exclusionary unless the patient has completed treatment. 14. Active infection with HIV, hepatitis C (HCV), or hepatitis B (HBV); 15. Recipient has a positive polymerase chain reaction (PCR) or antigen test for SARS CoV-2 at Screening; 16. Previous treatment with AT-1501 or any other anti-CD40LG or anti-CD40 therapy; 17. Medical conditions that require chronic use of systemic steroids at a dose higher than 5 mg prednisone or equivalent per day; 18. Treatment with an immunologic biologic compound (i.e., tumor necrosis factor inhibitors, [e.g., etanercept, adalimumab], IV immunoglobulin) within 90 days of Screening; 19. Treatment with corticosteroids, including budesonide, immunomodulators (e.g., thiopurines, calcineurin inhibitors), or experimental agents for IgAN within 30 days of Screening; 20. Menopausal hormone replacement therapies containing estrogen therapy alone (> 30 µg/day); 21. Concurrent participation in another interventional study or treatment with an investigational drug up to 30 days or 5 elimination half-lives (depending on medication) whichever is longer prior to Screening; 22. Any form of substance abuse, psychiatric disorder, or a condition that, in the opinion of the Investigator, could invalidate communication with the Investigator; 23. History of any other acute or chronic medical condition or pre-planned medical/surgical procedure that, in the opinion of the Investigator, would compromise the safety of the patient or the integrity of study results; 24. Unlikely to comply with the visits scheduled in the protocol, in the opinion of the Investigator.
    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy analysis endpoint is the change from baseline in UPCR over a 24-hour period at 24 weeks. The actual and percentage change from baseline to 24 weeks will be summarized in each cohort. A 2-sided 95% confidence interval will be presented for the point estimates.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Evaluations will be based on AEs, AEoSI and changes in vital signs, ECGs and clinical laboratory evaluations. • Safety analyses may include summaries of TEAEs, SAEs, TEAEs by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) grade and related TEAEs. • Laboratory, ECG, and vital sign changes from baseline will be summarized.
    E.5.2Secondary end point(s)
    • The change in eGFR slope from baseline to 96 weeks
    • The change in urine protein excretion over time
    • The percentage of patients who develop anti-drug antibodies (ADAs)
    E.5.2.1Timepoint(s) of evaluation of this end point
    Evaluations will be based on AEs, AEoSI and changes in vital signs, ECGs and clinical laboratory evaluations.
    • Safety analyses may include summaries of TEAEs, SAEs, TEAEs by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) grade and related TEAEs.
    • Laboratory, ECG, and vital sign changes from baseline will be summarized.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA15
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Australia
    China
    Malaysia
    New Zealand
    Philippines
    Sri Lanka
    Thailand
    Croatia
    Poland
    Spain
    E.8.7Trial has a data monitoring committee Yes
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months1
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months8
    E.8.9.2In all countries concerned by the trial days14
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1Number of subjects for this age range: 0
    F.1.1.1In Utero No
    F.1.1.1.1Number of subjects for this age range: 0
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.2.1Number of subjects for this age range: 0
    F.1.1.3Newborns (0-27 days) No
    F.1.1.3.1Number of subjects for this age range: 0
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.4.1Number of subjects for this age range: 0
    F.1.1.5Children (2-11years) No
    F.1.1.5.1Number of subjects for this age range: 0
    F.1.1.6Adolescents (12-17 years) No
    F.1.1.6.1Number of subjects for this age range: 0
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 30
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 12
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state10
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 20
    F.4.2.2In the whole clinical trial 42
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    n/a
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2022-10-05
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-04-28
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2023-07-31
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